Examiné médicalement par Kovalenko Svetlana Olegovna, Pharmacie Dernière mise à jour le 26.06.2023

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Chaque flacon d'Ozap poudre pour solution injectable contient 10 mg d'Ozap. Après reconstitution, chaque ml de solution contient 5 mg d'Ozap.
Les comprimés orodispersibles d'Ozap Zydis sont des préparations lyophilisées à disperser dans la bouche ou, alternativement, à disperser dans l'eau ou toute autre boisson appropriée pour l'administration.
Excipients / Ingrédients inactifs: Ozap : Comprimé enrobé de 5 mg et 10 mg: Noyau du comprimé: lactose monohydraté (156 mg et 312 mg, respectivement), hyprolose, crospovidone, cellulose microcristalline et stéarate de magnésium. Blason: Hypromellose, mélange de couleurs blanc (hypromellose, dioxyde de titane E171, macrogol, polysorbate 80), cire de carnauba, encre bleue comestible (shellac, éthanol anhydre, alcool isopropylique, alcool butylique, propylène glycol, hydroxyde d'ammonium, indigo carmin E132).
Poudre pour injection: Lactose monohydraté, acide chlorhydrique, acide tartrique, E334, hydroxyde de sodium.
Ozap Zydis : Comprimé orodispersible de 5 mg: Gélatine, mannitol (E421), aspartame (E951) 0,60 mg, parahydroxybenzoate de méthyle sodique (E219) 0,1125 mg, parahydroxybenzoate de propyle sodique (E217) 0,0375 mg.
Comprimé orodispersible de 10 mg: Gélatine, mannitol (E421), aspartame (E951) 0,80 mg, parahydroxybenzoate de méthyle sodique (E219) 0,15 mg, parahydroxybenzoate de propyle sodique (E217) 0,05 mg.
Schizophrénie
Les comprimés Ozap oraux, USP sont indiqués pour le traitement de la schizophrénie. L'efficacité a été établie dans trois essais cliniques chez des patients adultes atteints de schizophrénie: deux essais de 6 semaines et un essai d'entretien. Chez les patients adolescents atteints de schizophrénie (âgés de 13 à 17 ans), l'efficacité a été établie dans un essai de 6 semaines.
Lors de la décision parmi les traitements alternatifs disponibles pour les adolescents, les cliniciens doivent tenir compte du potentiel accru (chez les adolescents par rapport aux adultes) de prise de poids et de dyslipidémie. Les cliniciens devraient tenir compte des risques potentiels à long terme lors de la prescription aux adolescents, et dans de nombreux cas, cela peut les amener à envisager de prescrire d'autres médicaments d'abord chez les adolescents.
Trouble bipolaire I (épisodes maniaques ou mixtes)
Monothérapie -
Les comprimés Ozap oraux, USP sont indiqués pour le traitement aigu des épisodes maniaques ou mixtes associés au trouble bipolaire I et le traitement d'entretien du trouble bipolaire I. L'efficacité a été établie dans trois essais cliniques chez des patients adultes atteints d'épisodes maniaques ou mixtes de trouble bipolaire I: deux essais de 3 à 4 semaines et un essai d'entretien en monothérapie. Chez les patients adolescents souffrant d'épisodes maniaques ou mixtes associés au trouble bipolaire I (âgés de 13 à 17 ans), l'efficacité a été établie dans un essai de 3 semaines.
Lors de la décision parmi les traitements alternatifs disponibles pour les adolescents, les cliniciens doivent tenir compte du potentiel accru (chez les adolescents par rapport aux adultes) de prise de poids et de dyslipidémie. Les cliniciens devraient tenir compte des risques potentiels à long terme lors de la prescription aux adolescents, et dans de nombreux cas, cela peut les amener à envisager de prescrire d'autres médicaments d'abord chez les adolescents.
Thérapie d'appoint au lithium ou au valproate -
Les comprimés Ozap oraux, USP sont indiqués pour le traitement des épisodes maniaques ou mixtes associés au trouble bipolaire I en complément du lithium ou du valproate. L'efficacité a été établie dans deux essais cliniques de 6 semaines chez l'adulte. L'efficacité de la thérapie d'appoint pour une utilisation à plus long terme n'a pas été systématiquement évaluée dans les essais contrôlés.
Considérations spéciales dans le traitement de la schizophrénie pédiatrique et du trouble bipolaire I
La schizophrénie pédiatrique et le trouble bipolaire I sont de graves troubles mentaux; cependant, le diagnostic peut être difficile. Pour la schizophrénie pédiatrique, les profils des symptômes peuvent être variables et pour le trouble bipolaire I, les patients pédiatriques peuvent avoir des schémas variables de périodicité des symptômes maniaques ou mixtes. Il est recommandé de ne commencer la thérapie médicamenteuse pour la schizophrénie pédiatrique et le trouble bipolaire I qu'après une évaluation diagnostique approfondie et une attention particulière aux risques associés au traitement médicamenteux. Le traitement médicamenteux pour la schizophrénie pédiatrique et le trouble bipolaire I devrait faire partie d'un programme de traitement total qui comprend souvent des interventions psychologiques, éducatives et sociales.
Comprimés Ozap et fluoxétine en combinaison: épisodes dépressifs associés au trouble bipolaire I
Les comprimés Ozap oraux, USP et fluoxétine en association sont indiqués pour le traitement des épisodes dépressifs associés au trouble bipolaire I, sur la base d'études cliniques. Lorsque vous utilisez des comprimés Ozap, USP et la fluoxétine en combinaison, reportez-vous à la section Études cliniques de l'encart de colis pour Symbyax.
Ozap Tablets, USP monothérapie n'est pas indiqué pour le traitement des épisodes dépressifs associés au trouble bipolaire I.
Ozap est utilisé pour traiter les affections nerveuses, émotionnelles et mentales (par ex., schizophrénie). Il peut également être utilisé seul ou avec d'autres médicaments (par ex., lithium ou valproate) pour traiter le trouble bipolaire (maladie maniaco-dépressive) ou la manie qui fait partie du trouble bipolaire. Ozap ne doit pas être utilisé pour traiter les problèmes de comportement chez les patients adultes plus âgés atteints de démence ou de maladie d'Alzheimer.
Ozap n'est disponible qu'avec la prescription de votre médecin.
Une fois qu'un médicament a été approuvé pour la commercialisation pour une certaine utilisation, l'expérience peut montrer qu'il est également utile pour d'autres problèmes médicaux. Bien que cette utilisation ne soit pas incluse dans l'étiquetage des produits, Ozap est utilisé chez certains patients présentant les conditions médicales suivantes:
- Prévention des nausées et vomissements causés par les médicaments contre le cancer.
Schizophrenia
Adults
Dose Selection —
Oral Ozap should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for Ozap would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.
Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. Ozap is not indicated for use in doses above 20 mg/day.
Dosing in Special Populations — The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of Ozap (e.g., nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to Ozap. When indicated, dose escalation should be performed with caution in these patients.
Maintenance Treatment — The effectiveness of oral Ozap, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on Ozap Tablets for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial. The physician who elects to use Ozap Tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Adolescents
Dose Selection —
Oral Ozap should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with schizophrenia was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 12.5 mg/day (mean dose of 11.1 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials.
Maintenance Treatment — The efficacy of Ozap Tablets for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of Ozap pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Bipolar I Disorder (Manic or Mixed Episodes)
Adults
Dose Selection for Monotherapy —
Oral Ozap should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.
Short-term (3 to 4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials.
Maintenance Monotherapy — The benefit of maintaining bipolar I patients on monotherapy with oral Ozap Tablets at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of 2 weeks, was demonstrated in a controlled trial. The physician who elects to use Ozap Tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Dose Selection for Adjunctive Treatment — When administered as adjunctive treatment to lithium or valproate, oral Ozap dosing should generally begin with 10 mg once-a-day without regard to meals.
Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials.
Adolescents
Dose Selection —
Oral Ozap should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 10.7 mg/day (mean dose of 8.9 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials.
Maintenance Treatment — The efficacy of Ozap Tablets for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of Ozap pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Ozap Tablets and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder
When using Ozap Tablets and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. When using Ozap Tablets and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Adults
Oral Ozap should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral Ozap and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of oral Ozap 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with Ozap Tablets and fluoxetine in combination in adult patients with a dose range of Ozap 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg Ozap with 75 mg fluoxetine has not been evaluated in clinical studies.
Oral Ozap should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral Ozap and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of oral Ozap 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with Ozap Tablets and fluoxetine in combination in adult patients with a dose range of Ozap 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg Ozap with 75 mg fluoxetine has not been evaluated in clinical studies.
Children and Adolescents (10 to 17 years of age)
Dosage and Administration information for pediatric patients (10 to 17) is approved for Eli Lilly and Company's Ozap Tablets. However, due to Eli Lilly and Company's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Safety and efficacy of Ozap Tablets and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of Ozap Tablets and fluoxetine). Symbyax is dosed between 3 mg/25 mg (Ozap/fluoxetine) per day and 12 mg/50 mg (Ozap/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of Ozap Tablets and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.
Safety and efficacy of Ozap Tablets and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of Ozap Tablets and fluoxetine). Symbyax is dosed between 3 mg/25 mg (Ozap/fluoxetine) per day and 12 mg/50 mg (Ozap/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of Ozap Tablets and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.
- Table 1: Approximate Dose Correspondence Between Symbyax a and the Combination of Ozap Tablets and Fluoxetine
While there is no body of evidence to answer the question of how long a patient treated with Ozap Tablets and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy. While there is no body of evidence to answer the question of how long a patient treated with Ozap Tablets and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
Ozap Tablets monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder. Ozap Tablets monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.
Ozap Tablets and Fluoxetine in Combination: Dosing in Special Populations
The starting dose of oral Ozap 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of Ozap or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to Ozap. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Ozap Tablets and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients under <10 years of age.
Use Ozap orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ozap orally disintegrating tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ozap orally disintegrating tablets refilled.
- Take Ozap orally disintegrating tablets by mouth with or without food.
- Make sure that your hands are dry before you touch Ozap orally disintegrating tablets.
- Ozap orally disintegrating tablets may come in a bottle or a blister pack. If it comes in a blister pack, do not remove the blister from the outer pouch until you are ready to take Ozap orally disintegrating tablets. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
- The tablet dissolves quickly and can be swallowed with saliva. Ozap orally disintegrating tablets may be taken with or without water.
- Drinking extra fluids while you are taking Ozap orally disintegrating tablets is recommended. Check with your doctor for instructions.
- Continue to take Ozap orally disintegrating tablets even if you feel well. Do not miss any doses.
- If you miss a dose of Ozap orally disintegrating tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ozap orally disintegrating tablets.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Agitation/Aggression (acute) associated with psychiatric disorders (short-acting IM): Treatment of acute agitation associated with schizophrenia and bipolar I mania.
Bipolar disorder (oral): Treatment of acute manic or mixed episodes of bipolar I disorder (as monotherapy or in combination with lithium or valproate) and maintenance treatment; treatment of bipolar depression in combination with fluoxetine.
Major depressive disorder (unipolar), treatment resistant (oral): Treatment of treatment-resistant depression in combination with fluoxetine.
Schizophrenia (oral, ER IM): Treatment of the manifestations of schizophrenia.
Off Label Uses
Agitation/Aggression and psychosis associated with dementia
Data from randomized, double-blind, controlled trials support the use of Ozap in the treatment of psychosis and agitation related to dementia.
Based on the APA practice guideline for the treatment of patients with major depressive disorder and the WFSBP guidelines for biological treatment of unipolar depressive disorders, in patients with psychotic depression, the combination of an antidepressant and antipsychotic is recommended at the onset of treatment.
See also:
What other drugs will affect Ozap?
The risks of using Ozap in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of Ozap, caution should be used when Ozap is taken in combination with other centrally acting drugs and alcohol.
Because of its potential for inducing hypotension, Ozap may enhance the effects of certain antihypertensive agents.
Ozap may antagonize the effects of levodopa and dopamine agonists.
The Effect of Other Drugs on Ozap — Agents that induce CYP1A2 or glucuronyl transferase enzymes, such as omeprazole and rifampin, may cause an increase in Ozap clearance. Inhibitors of CYP1A2 could potentially inhibit Ozap clearance. Although Ozap is metabolized by multiple enzyme systems, induction or inhibition of a single enzyme may appreciably alter Ozap clearance. Therefore, a dosage increase (for induction) or a dosage decrease (for inhibition) may need to be considered with specific drugs.
Charcoal — The administration of activated charcoal (1 g) reduced the Cmax and AUC of oral Ozap by about 60%. As peak Ozap levels are not typically obtained until about 6 hours after dosing, charcoal may be a useful treatment for Ozap overdose.
Cimetidine and Antacids — Single doses of cimetidine (800 mg) or aluminum- and magnesium-containing antacids did not affect the oral bioavailability of Ozap.
Carbamazepine — Carbamazepine therapy (200 mg bid) causes an approximately 50% increase in the clearance of Ozap. This increase is likely due to the fact that carbamazepine is a potent inducer of CYP1A2 activity. Higher daily doses of carbamazepine may cause an even greater increase in Ozap clearance.
Ethanol — Ethanol (45 mg/70 kg single dose) did not have an effect on Ozap pharmacokinetics.
Fluoxetine — Fluoxetine (60 mg single dose or 60 mg daily for 8 days) causes a small (mean 16%) increase in the maximum concentration of Ozap and a small (mean 16%) decrease in Ozap clearance. The magnitude of the impact of this factor is small in comparison to the overall variability between individuals, and therefore dose modification is not routinely recommended.
Fluvoxamine — Fluvoxamine, a CYP1A2 inhibitor, decreases the clearance of Ozap. This results in a mean increase in Ozap Cmax following fluvoxamine of 54% in female nonsmokers and 77% in male smokers. The mean increase in Ozap AUC is 52% and 108%, respectively. Lower doses of Ozap should be considered in patients receiving concomitant treatment with fluvoxamine.
Warfarin — Warfarin (20 mg single dose) did not affect Ozap pharmacokinetics.
Lithium — Multiple doses of Ozap (10 mg for 8 days) did not influence the kinetics of lithium. Therefore, concomitant Ozap administration does not require dosage adjustment of lithium.
Valproate —In vivo administration of Ozap (10 mg daily for 2 weeks) did not affect the steady state plasma concentrations of valproate. Therefore, concomitant Ozap administration does not require dosage adjustment of valproate.
The co-administration of either diazepam or ethanol with Ozap potentiated the orthostatic hypotension observed with Ozap. Multiple doses of Ozap did not affect the pharmacokinetics of theophylline or its metabolites.
See also:
What are the possible side effects of Ozap?
Clinical Trials Experience
The information below for Ozap RELPREVV is derived primarily from a clinical trial database consisting of 2058 patients with approximately 1948 patient years of exposure to Ozap RELPREVV. This database includes safety data from 6 open-label studies and 2 double-blind comparator studies, conducted in patients with schizophrenia or schizoaffective disorder. Additionally, data obtained from patients treated with oral Ozap are also presented below. Adverse reactions were assessed by the collection of adverse reactions, vital signs, weights, laboratory analytes, ECGs, and the results of physical and ophthalmologic examinations. In the tables and tabulations that follow for Ozap RELPREVV, the MedDRA terminology has been used to classify reported adverse reactions. Data obtained from oral Ozap studies was reported using the COSTART and MedDRA dictionaries.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Reactions listed elsewhere in labeling may not be repeated below. The entire label should be read to gain a complete understanding of the safety profile of Ozap RELPREVV.
The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse reaction incidence in the population studied.
Adverse Reactions Associated With Discontinuation Of Treatment In A Short-Term, Placebo-Controlled Trial
Overall, there was no difference in the incidence of discontinuation due to adverse reactions between Ozap RELPREVV (4%; 13/306 patients) and placebo (5%; 5/98 patients) in an 8-week trial.
Commonly Observed Adverse Reactions In A Short-Term, Placebo-Controlled Trial
In an 8-week trial, treatment-emergent adverse reactions with an incidence of 5% or greater in at least one of the Ozap RELPREVV treatment groups (210 mg/2 weeks, 405 mg/4 weeks, or 300 mg/2 weeks) and greater than placebo were: headache, sedation, weight gain, cough, diarrhea, back pain, nausea, somnolence, dry mouth, nasopharyngitis, increased appetite, and vomiting.
Adverse Reactions Occurring At An Incidence Of 2% Or More Among Ozap RELPREVV-Treated Patients In A Short-Term, Placebo-Controlled Trial
Table 9 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred in 2% or more of patients treated with Ozap RELPREVV and with incidence greater than placebo who participated in the 8-week, placebo-controlled trial.
Table 9: Treatment-Emergent Adverse Reactions: Incidence in a Short-Term, Placebo-Controlled Clinical Trial with Ozap RELPREVV
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Disponible dans les pays
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Placebo (N=98) | Ozap RELPREVV 405 mg/4 wks (N=100) | Ozap RELPREVV 210 mg/2 wks (N=106) | Ozap RELPREVV 300 mg/2 wks (N=100) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Ear pain | 2 | 1 | 1 | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Gastrointestinal Disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abdominal pain Adjusted for gender.Vital Signs And Laboratory StudiesLaboratory Changes Ozap RELPREVV in Adults: Statistically significant within group mean changes for Ozap RELPREVV, which were also significantly different from placebo, were observed for the following: eosinophils, monocytes, cholesterol, low-density lipoprotein (LDL), triglycerides, and direct bilirubin. There were no statistically significant differences between Ozap RELPREVV and placebo in the incidence of potentially clinically significant changes in any of the laboratory values studied. Statistically significant within group mean changes for Ozap RELPREVV, which were also significantly different from oral Ozap (in a 24-week double-blind study), were observed for the following: gammaglutamyltransferase (GGT) and sodium. From an analysis of the laboratory data in an integrated database of 41 completed clinical studies in adult patients treated with oral Ozap, high GGT levels were recorded in ≥1% (88/5245) of patients. Statistically significant differences were observed between Ozap RELPREVV and oral Ozap for the incidence of treatment-emergent low platelet count (0% Ozap RELPREVV vs 1% oral Ozap); and low total bilirubin (2.8% Ozap RELPREVV vs 0.7% for oral Ozap). There was a statistically significant difference between Ozap RELPREVV and oral Ozap in potentially clinically significant changes for high leukocyte count (0% Ozap RELPREVV vs 1% oral Ozap). Changes in aminotransferases observed with Ozap RELPREVV treatment were similar to those reported with Ozap treatment. In placebo-controlled Ozap RELPREVV studies, clinically significant ALT elevations (≥3 times the upper limit of the normal range) were observed in 2.7% (8/291) of patients exposed to Ozap compared to 3.2% (3/94) of the placebo patients. None of these patients experienced jaundice. In 3 of these patients, liver enzymes reverted to the normal range despite continued treatment, and in 5 cases enzymes values decreased, but were still above the normal range at the end of therapy. Within the larger premarketing Ozap RELPREVV database of 1886 patients with baseline ALT ≤90 IU/L, the incidence of ALT elevation to >200 IU/L was 0.8%. None of these patients experienced jaundice or other symptoms attributable to liver impairment and most had transient changes that tended to normalize while Ozap RELPREVV treatment was continued. From an analysis of the laboratory data in an integrated database of 41 completed clinical studies in adult patients treated with oral Ozap, elevated uric acid was recorded in ≥3% (171/4641) of patients. Ozap Monotherapy in Adults: An assessment of the premarketing experience for oral Ozap revealed an association with asymptomatic increases in ALT, AST, and GGT. Within the original premarketing database of about 2400 adult patients with baseline ALT ≤90 IU/L, the incidence of ALT elevations to >200 IU/L was 2% (50/2381). None of these patients experienced jaundice or other symptoms attributable to liver impairment and most had transient changes that tended to normalize while Ozap treatment was continued. In placebo-controlled oral Ozap monotherapy studies in adults, clinically significant ALT elevations (change from <3 times the upper limit of normal [ULN] at baseline to ≥3 times ULN) were observed in 5% (77/1426) of patients exposed to Ozap compared to 1% (10/1187) of patients exposed to placebo. ALT elevations ≥5 times ULN were observed in 2% (29/1438) of Ozap-treated patients, compared to 0.3% (4/1196) of placebo-treated patients. ALT values returned to normal, or were decreasing, at last follow-up in the majority of patients who either continued treatment with Ozap or discontinued Ozap. No patient with elevated ALT values experienced jaundice, liver failure, or met the criteria for Hy’s Rule. Caution should be exercised in patients with signs and symptoms of hepatic impairment, in patients with preexisting conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic drugs. Oral Ozap administration was also associated with increases in serum prolactin, with an asymptomatic elevation of the eosinophil count in 0.3% of patients, and with an increase in CPK. ECG Changes Comparison of Ozap RELPREVV and oral Ozap, in a 24 week study, revealed no significant differences on ECG changes. Between-group comparisons for pooled placebo-controlled trials revealed no significant oral Ozap/placebo differences in the proportions of patients experiencing potentially important changes in ECG parameters, including QT, QTc, and PR intervals. Oral Ozap use was associated with a mean increase in heart rate of 2.4 beats per minute compared to no change among placebo patients. This slight tendency to tachycardia may be related to Ozap’s potential for inducing orthostatic changes. Postmarketing ExperienceAdverse reactions reported since market introduction that were temporally (but not necessarily causally) related to Ozap therapy include the following: allergic reaction (e.g., anaphylactoid reaction, angioedema, pruritus or urticaria), cholestatic or mixed liver injury, diabetic coma, diabetic ketoacidosis, discontinuation reaction (diaphoresis, nausea, or vomiting), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), hepatitis, jaundice, neutropenia, pancreatitis, priapism, rash, rhabdomyolysis, and venous thromboembolic events (including pulmonary embolism and deep venous thrombosis). Random cholesterol levels of ≥240 mg/dL and random triglyceride levels of ≥1000 mg/dL have been reported. Additionally, injection site abscess has been reported in postmarketing reports with Ozap RELPREVV therapy. Isolated cases required surgical intervention. Ozap contraindicationsSee also: Ozap is not for use in psychotic conditions related to dementia. Ozap may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You may gain weight or have high cholesterol and triglycerides (types of fat) while taking this medicine, especially if you are a teenager. Your blood may need to be tested often. Visit your doctor regularly. Ozap can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking Ozap. Ozap may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Avoid drinking alcohol while taking Ozap. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Ozap.
Active ingredient matches for Ozap:Olanzapine in India.
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